# K082641: Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DL

- Pathway: 510(k) (Special)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Nov 10, 2008 after 60 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001085 (2000). 4 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073454: Fingertip Pulse Oximeter, Model CMS-50C, Contec Medical System Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K140582: Fingertip Pulse Oximeter (2014), 6 descendants of its own
- K163135: Finger Pulse Oximeter (2017), 4 descendants of its own
- K203854: Pulse Oximeter (2021), 1 descendant of its own
- K213430: Fingertip Pulse Oximeter (2022), 0 descendants of its own
- K213984: Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) (2022), 0 descendants of its own

## Indications for use
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO 2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K082641
Methodology: https://510kreport.com/methodology